MAUDE Adverse Event Report: BETA10 HCG ULTRA COMBO; HCG PREGNANCY TEST

Model Number IFM07KUS03

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer's observation was not replicated in-house with retention devices.Retention products were tested with hcg urine at 10miu/ml, 206.7iu/ml, 212.4iu/ml, 225.8iu/ml, as well as hcg serum at 10miu/ml.All of the results were hcg positive at read time and met qc release specification.No false negatives were obtained during in-house testing.Manufacturing batch record review did not uncover any abnormalities.A root cause could not be determined from the information provided by the customer.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

Event Description

Report received of false negative hcg results on beta10 hcg ultra combo.Event occurred in (b)(6).Patient received positive hcg results on an unspecified home pregnancy test.Patient confirmed to be pregnant per beta hcg (blood) = pos.Values not reported.Second test lot if-m07kus03-90 = pos.No reported adverse patient sequela.No additional information provided.

• Brand Name: BETA10 HCG ULTRA COMBO
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 6125875
• MDR Text Key: 60906215
• Report Number: 2027969-2016-00693
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IFM07KUS03
• Device Lot Number: IF-MOTKUS03-89
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1